Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:07 PM
Study NCT ID:
NCT03897998
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2019-03-29
Brief Title:
Neural Correlates of Hypoalgesia Driven by Observation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Neural Correlates of Hypoalgesia Driven by Observation
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Placebo effects held an ambivalent place in health care for at least two centuries On the one hand placebos are traditionally used as controls in clinical trials to correct for biases and the placebo response is viewed as an effect to be factored out in order to isolate and accurately measure the effects of the treatment On the other hand there is scientific evidence that placebo effects represent fascinating psychoneurobiological events involving the contribution of distinct central nervous as well as peripheral physiological mechanisms that influence pain perception and clinical pain symptoms and substantially modulate the response to pain therapeutics Therefore placebo effects have shifted from being a challenge for clinical trials to a resource to trigger the reduction of pain based on endogenous mechanisms that can be activated in the brain to promote hypolagesia self-healing and well-being This is relevant in acute pain settings given that chronic opioid users die within approximately 25 years of being prescribed their first opioid medication to treat acute pain
The overall hypothesis is that observational learning influences neural pain modulation and cognition systems including processes associated with mentalizing the ability to cognitively understand mental states of others empathy the ability to share an emotional experience and expectancy the anticipation of a benefit The objective is to determine the brain mechanisms of observationally-induced analgesia using brain mapping approaches that target changes in blood oxygenation and oscillatory activity in the brain thus enabling investigators to draw inferences about the localization and extent of neurobiological activation underlying hypoalgesia driven by observation Therefore the investigators designed innovative experiments using pharmacological fMRI EEG and combined EEG-fMRI measurements
The overall hypothesis is that observational learning influences neural pain modulation and cognition systems including processes associated with mentalizing the ability to cognitively understand mental states of others empathy the ability to share an emotional experience and expectancy the anticipation of a benefit The objective is to determine the brain mechanisms of observationally-induced analgesia using brain mapping approaches that target changes in blood oxygenation and oscillatory activity in the brain thus enabling investigators to draw inferences about the localization and extent of neurobiological activation underlying hypoalgesia driven by observation Therefore the investigators designed innovative experiments using pharmacological fMRI EEG and combined EEG-fMRI measurements
Detailed Description:
Analgesic effects can also occur without formal conditioning and direct prior experience because crucial information necessary to build up expectations of analgesia can be acquired through observation of a therapeutic benefit in others Placebo analgesic effects following the observation of a benefit in another person are similar in magnitude to those induced by directly experiencing an analgesic benefit These observations emphasize that contextual cues substantially modulate the individual placebo analgesic effects
In this project the investigators propose a compelling research agenda to explore the neural mechanisms of hypoalgesia driven by observation as a foundation for future development of novel nonpharmacological pain therapies using pharmacological functional magnetic resonance imaging fMRI electroencephalography EEG and combined EEGfMRI It builds on a decade of experience in placebo research in PI Collocas lab and with University of Maryland collaborators experienced in brain mapping and pain research In Aim 1 the investigators will determine the role of endogenous opioids on the neural mechanisms of observationally-induced hypoalgesia by using the opioid antagonist naloxone in a functional Magnetic Resonance Imaging fMRI setting In Aim 2 the investigators will identify the impact of empathy by exploring how being in the immersive environment can enhance observationally-induced analgesia In Aim 3 the investigators will leverage the EEGfMRI to determine the neural EEGfMRI transient changes that could co-occur when socially-induced expectations are violated
In this project the investigators propose a compelling research agenda to explore the neural mechanisms of hypoalgesia driven by observation as a foundation for future development of novel nonpharmacological pain therapies using pharmacological functional magnetic resonance imaging fMRI electroencephalography EEG and combined EEGfMRI It builds on a decade of experience in placebo research in PI Collocas lab and with University of Maryland collaborators experienced in brain mapping and pain research In Aim 1 the investigators will determine the role of endogenous opioids on the neural mechanisms of observationally-induced hypoalgesia by using the opioid antagonist naloxone in a functional Magnetic Resonance Imaging fMRI setting In Aim 2 the investigators will identify the impact of empathy by exploring how being in the immersive environment can enhance observationally-induced analgesia In Aim 3 the investigators will leverage the EEGfMRI to determine the neural EEGfMRI transient changes that could co-occur when socially-induced expectations are violated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None